FDA.reportPublic FDA data

Charm-Tex FLUORIDE Gel

Product NDC
77573-012
Requested package NDC
77573-012-07
11-digit product format
775730012
Labeler code
77573
Product ID
77573-012_e391a873-77a6-d312-e053-2995a90af9da
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Jiangsu Aimeili Cosmetic Co.,Ltd.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-07-10
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage77573-01277573-012-07IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
77573-012-0177573-012
77573-012-0277573-012
77573-012-0377573-012
77573-012-0477573-012
77573-012-0577573-012
77573-012-0677573-012
77573-012-0777573-012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77573-012-01Charm-Tex FLUORIDE Gel1000 in 1 PACKAGEPASTE, DENTIFRICE10002
77573-012-01Charm-Tex FLUORIDE Gel7.1 g in 1 TUBEPASTE, DENTIFRICE7.12
77573-012-02Charm-Tex FLUORIDE Gel17 g in 1 TUBEPASTE, DENTIFRICE172
77573-012-02Charm-Tex FLUORIDE Gel720 in 1 PACKAGEPASTE, DENTIFRICE7202
77573-012-03Charm-Tex FLUORIDE Gel24 g in 1 TUBEPASTE, DENTIFRICE242
77573-012-03Charm-Tex FLUORIDE Gel720 in 1 PACKAGEPASTE, DENTIFRICE7202
77573-012-04Charm-Tex FLUORIDE Gel144 in 1 PACKAGEPASTE, DENTIFRICE1442
77573-012-04Charm-Tex FLUORIDE Gel43 g in 1 TUBEPASTE, DENTIFRICE432
77573-012-05Charm-Tex FLUORIDE Gel78 g in 1 TUBEPASTE, DENTIFRICE782
77573-012-05Charm-Tex FLUORIDE Gel144 in 1 PACKAGEPASTE, DENTIFRICE1442
77573-012-06Charm-Tex FLUORIDE Gel130 g in 1 TUBEPASTE, DENTIFRICE1302
77573-012-06Charm-Tex FLUORIDE Gel60 in 1 PACKAGEPASTE, DENTIFRICE602
77573-012-07Charm-Tex FLUORIDE Gel60 in 1 PACKAGEPASTE, DENTIFRICE602
77573-012-07Charm-Tex FLUORIDE Gel181 g in 1 TUBEPASTE, DENTIFRICE1812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77573-012CHARM-TEX FLUORIDE GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [JIANGSU AIMEILI COSMETIC CO.,LTD.]2Legacy NDC, 14 package rows20240105_fa04010f-6c5c-4921-a1f7-e1770e9aef12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSNfa04010f-6c5c-4921-a1f7-e1770e9aef122
245598sodium fluoride 0.0022 MG/MG ToothpasteSCDfa04010f-6c5c-4921-a1f7-e1770e9aef122
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSYfa04010f-6c5c-4921-a1f7-e1770e9aef122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77573-012-077757300120760 TUBE in 1 PACKAGE (77573-012-07) > 181 g in 1 TUBE60 tube2022-07-110000-00-00NoNoCurrent